Impact of an integrated care program on glycemic control and cardiovascular risk factors in patients with type 2 diabetes in Saudi Arabia: an ...

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Tourkmani et al. BMC Family Practice (2018) 19:1
DOI 10.1186/s12875-017-0677-2

 RESEARCH ARTICLE                                                                                                                              Open Access

Impact of an integrated care program on
glycemic control and cardiovascular risk
factors in patients with type 2 diabetes in
Saudi Arabia: an interventional parallel-
group controlled study
Ayla M. Tourkmani, Osama Abdelhay, Hesham I. Alkhashan, Aboud F. Alaboud, Ahmed Bakhit, Tarek Elsaid,
Ahmed Alawad, Aljohara Alobaikan, Hala Alqahtani, Abdulaziz Alqahtani, Adel Mishriky, Abdulaziz bin Rsheed
and Turki J. Alharbi*

  Abstract
  Background: Long intervals between patient visits and limited time with patients can result in clinical inertia and
  suboptimal achievement of treatment goals. These obstacles can be improved with a multidisciplinary care program.
  The present study aimed to assess the impact of such a program on glycemic control and cardiovascular risk factors.
  Methods: In a randomized, parallel-group trial, we assigned 263 patients with poorly controlled type 2 diabetes
  mellitus (T2DM) to either a control group, standard care program, or a multidisciplinary care program involving a senior
  family physician, clinical pharmacy specialist, dietician, diabetic educator, health educator, and social worker. The
  participants were followed for a median of 10 months, between September 2013 and September 2014. Glycated
  hemoglobin (HbA1c), fasting blood glucose (FBG), lipid profiles, and blood pressure (BP) were measured. The assignment
  was blinded for the assessors of the study outcomes. The study registry number is.
  Results: In the intervention group, there were statistically significant (p < 0.05) post-intervention (relative) reductions in
  the levels of HbA1c (−27.1%, 95% CI = −28.9%, −25.3%), FBG (−17.10%, 95% CI = −23.3%, −10.9%), total cholesterol
  (−9.93%, 95% CI = −12.7%, −7.9%), LDL cholesterol (−11.4%, 95% CI = −19.4%, −3.5%), systolic BP (−1.5%, 95% CI = −2.9%,
  −0.03%), and diastolic BP (−3.4%, 95% CI = −5.2%, −1.7%). There was a significant decrease in the number of patients with
  a HbA1c ≥10 (86 mmol/mol) from 167 patients at enrollment to 11 patients after intervention (p < 0.001). However, the
  intervention group experienced a statistically significant increase in body weight (3.7%, 95% CI = 2.9%, 4.5%). In the control
  group, no statistically significant changes were noticed in different outcomes with the exception of total cholesterol
  (−4.10%, p = 0.07). In the linear regression model, the intervention and the total number of clinic visits predicted HbA1c
  improvement.
  Conclusions: Implementation of a patient-specific integrated care program involving a multidisciplinary team approach,
  frequent clinic visits, and intensified insulin treatment was associated with marked improvement in glycemic control and
  cardiovascular risk factors of poorly controlled T2DM patients in a safe and reproducible manner.
  Trial registration: ISRCTN Identifier: ISRCTN83437562 September 19, 2016 Retrospectively registered.
  Keywords: Type 2 diabetes, Cardiovascular risk, Glycemic control, Multidisciplinary care

* Correspondence: turkifcm@yahoo.com
Family and Community Medicine Department, Prince Sultan Military Medical
City, P.O. Box 7897, Riyadh 11159, Saudi Arabia

                                      © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
                                      International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
                                      reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
                                      the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
                                      (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Tourkmani et al. BMC Family Practice (2018) 19:1                                                               Page 2 of 10

Background                                                    Center is staffed by senior family physicians who are
Saudi Arabia has one of the highest rates of diabetes in      board certified and/or specialized in diabetes care, a
the world [1]. Local population studies estimate the          board certified clinical pharmacist, dieticians, diabetic
prevalence of diabetes at approximately 24% among             educators, health educators, and social workers. The
Saudi adults [2]. This is approximately three times the       daily clinics are run by six physicians serving approxi-
world average [1]. A recent epidemiologic forecast study      mately 120 patients daily.
that incorporated the high obesity and smoking preva-
lence trends among Saudi adults estimated type 2 dia-         Design
betes mellitus (T2DM) at 44% in 2022 [3]. In addition to      A randomized, controlled interventional study was con-
the associated increased risk of morbidity and mortality,     ducted between September 2013 and September 2014.
T2DM among Saudis has led to a surge in healthcare            Enrollment data were assessed by reviewing the patient
utilization and allocated costs [4]. Diabetes is known to     charts for at least two visits before joining the study.
increase the risk of vascular diseases such as heart dis-     Outcome data were assessed by prospectively following
eases and stroke markedly [5]. This can be averted, or at     patients for at least two visits after joining the study (for
least delayed, by intensive glycemic control [6, 7], along    a maximum of 9 months). Controls were recruited from
with the control of associated risk factors such as hyper-    the same center using the same eligibility criteria. All
tension and dyslipidemia [7–9]. However, the compli-          required ethical approvals from the local ethical commit-
ance with these preventive measures by patients with          tee were obtained before data collection.
T2DM is inadequate [10, 11].
   Primary care physicians manage most patients with          Population and eligibility
T2DM. However, long intervals between patient visits          The study sample was recruited from adult patients,
and limited time with patients can result in clinical iner-   18 years or older, with T2DM who received their dia-
tia and, consequently, suboptimal achievement of treat-       betic care at the Chronic Diseases Center of WHC.
ment goals [12, 13]. Several strategies have been             Patients who had at least two clinic visits before joining
described to overcome barriers to efficient diabetes man-     the study and were able to provide informed consent
agement at primary care settings, including a multidis-       were checked for eligibility for enrollment. Patients who
ciplinary team approach [12, 14]. The implementation of       received care from both diabetes clinics at the endocrin-
such an approach was successful in improving diabetes         ology department and primary care clinics were ex-
care in primary care patients [15]. We have reported a        cluded to avoid double care and to assure a standardized
successful integrated care program for improving dia-         level of management. The eligibility criteria included
betes management in Saudi Arabia [16]. However, the           one or more of the following: (1) poor glycemic control
small sample size and the lack of control limited the in-     (HbA1c >10 [86 mmol/mol] or persistent elevation of
ferences from the study findings. The aim of the current      HbA1c >8 [64 mmol/mol] for 1 year or more); (2) failure
study was to evaluate the impact of a multidisciplinary       to respond to therapeutic insulin dose of >2 units/kg or
diabetic care program on glycated hemoglobin (HbA1c)          200 units irrespective of weight; (3) inadequate adher-
and cardiovascular risk factors among patients with           ence to insulin; (4) uncontrolled hypertension or hyper-
poorly controlled T2DM in a primary care setting, using       lipidemia with maximum possible combination of
a controlled interventional design. The study assessed        medications; (5) comorbidity such as cardiovascular,
changes in HbA1c, fasting blood glucose (FBG), total          renal, or hepatic disease; and (6) inadequate continuity
cholesterol, triglycerides, HDL cholesterol, LDL choles-      of care (such as recurrent missed appointments for insu-
terol, systolic and diastolic blood pressure (BP), body       lin titration). The eligible patients were consecutively
weight, number of visits, and record of concomitant           assigned to either the intervention or control groups
medications and the frequency of adjustment.                  using a computerized random number generator. The
                                                              289 patients were assigned unique study numbers ran-
Methods                                                       ging from 1 to 289. The number assigned was consistent
Setting                                                       with the recruitment date (i.e., the first patient recruited
The study was conducted in Al-Wazarat Chronic                 was assigned the number 1 and the last patient recruited
Diseases Center, a division of the Al-Wazarat Health          was assigned the number 289). The clinical pharmacist
Care (WHC) Family Medicine Center in Riyadh, Saudi            who acted as the case manager conducted assigned
Arabia. The Chronic Diseases Center consists of 12 spe-       study numbers. The biostatistician generated a random
cialized clinics, primarily for patients with T2DM, hyper-    sequence of 72 numbers out of 289 using a computer
tension, dyslipidemia, and bronchial asthma, in addition      program without knowing the order of the patients. The
to a procedures room and support services such as phar-       case manager assigned the patients’ numbers who
macy, laboratory, and radiology. The Chronic Diseases         matched those on the random sequence to the control
Tourkmani et al. BMC Family Practice (2018) 19:1                                                                        Page 3 of 10

group. The recruitment and randomization processes of                   and triglycerides), BP (systolic and diastolic), and body
the patients are illustrated in Fig. 1.                                 weight during the study relative to baseline were the
                                                                        outcomes measured.
Sample size
Considering the results of the pilot study, we proposed                 Intervention
that an integrated care program can reduce HbA1c by 3                   The integrated care program is a multidisciplinary pro-
points and FBG by 3 mmol/L. To detect a 2-point differ-                 gram used for the care of patients in the intervention
ence in HbA1c (3.0 versus 1.0 with a standard deviation                 group. Patients were referred from any discipline work-
[SD] of 2.7) between the intervention and control groups                ing in the Chronic Diseases Center when they fulfilled
with 80% power and 95% confidence, 80 patients were                     the eligibility criteria for the integrated care program to
required (60 in the intervention and 20 in the control                  the case manager. The program team included a senior
group, assuming a ratio of 3:1). Similarly, to detect a dif-            family physician, clinical pharmacy specialist who acted
ference of 2 mmol/L in FBG (3.0 versus 1.0 with a SD of                 as a case manager, dietician, diabetic educator, health
5.0) between the intervention and control groups with                   educator, and social worker. The program team met
80% power and 95% confidence, 264 patients were re-                     once or twice weekly to review the eligibility of referred
quired (198 in the intervention and 66 in the control                   patients and to assess and decide on the care plans for
group, assuming a ratio of 3:1). Therefore, the larger                  those who had already been enrolled. The care provided
sample size was adopted. The researchers opted to select                was the standard care per the guidelines of the American
a smaller size for the control group compared with the                  Diabetes Association (ADA) [17], but intensified with
intervention (1 to 3) to maximize the number of patients                consideration for individual clinical and social factors.
gaining potential benefits from the intervention.                       The case manager was responsible for arranging re-
                                                                        quired appointments with other specialties as per the
Outcome                                                                 care plan, as well as evaluating the compliance and ad-
The absolute and relative changes in the levels of                      verse effects of the new plan, through at least weekly ap-
HbA1c, FBG, blood lipids (total, LDL, HDL cholesterol,                  pointments in the first 3 months. Enrolled patients had

 Fig. 1 Flow diagram of the progress in a randomized controlled trial
Tourkmani et al. BMC Family Practice (2018) 19:1                                                             Page 4 of 10

to be seen at least once by all members of the program        of change in the study outcomes was defined as the
team during the period of enrollment, with the excep-         amount of change during the study relative to baseline
tion of the social worker who was seen on an as-needed        at enrollment. The change in the levels of the study out-
basis. Strategies to improve the care were patient-based      comes was examined using a paired t-test. The correla-
and included (but not limited to) providing more clinic       tions between the change in HbA1c and the patient’s age
visits, frequent monitoring of outcomes, improving            and clinical and management factors were examined
multidisciplinary communication and coordination, pro-        using Spearman’s correlation. Independent predictors of
viding additional diabetic education and dietetic advice,     HbA1c change were evaluated using a multivariate linear
promoting self-management, providing a booklet for            regression model. All p-values were two-tailed. P-values
home blood glucose monitoring, adjusting doses accord-
Tourkmani et al. BMC Family Practice (2018) 19:1                                                                           Page 5 of 10

Table 1 Demographic and clinical data of the study groups at              multiple daily doses (p < 0.001), and more total insulin
enrollment                                                                daily dose per kg (1.3 ± 0.7 versus 0.6 ± 0.4, p < 0.001)
                              Intervention     Control         p-valuea   compared with the control group. They also had signifi-
                              (N = 195)        (N = 68)                   cantly higher total number of visits (11.9 ± 6.6 versus
Age (years)                                                               5.1 ± 4.8, p < 0.001), as well as visits to a case manager,
    < 50                      47 (24.1%)       15 (22.1%)                 diabetes educator, and health educator compared with
    50-59                     68 (34.9%)       22 (32.4%)                 the control group.
    ≥ 60                      80 (41.0%)       31 (45.6%)
                                                                             The enrollment and final levels, as well as the changes
                                                                          in the study outcomes, are shown in Table 2. In the
    Range                     20-85            33-83
                                                                          intervention group, there were significant decreases in
    Mean ± SDb                56.9 ± 12.0      57.7 ± 11.6     0.649      the percentage of change relative to baseline in the levels
Sex                                                                       of HbA1c (−27.08%, p < 0.001), FBG (−17.0%, p < 0.001),
    Male (92)                 67 (34.4%)       25 (36.8%)      0.720      total cholesterol (−9.93%, p < 0.001), LDL cholesterol
    Female (171)              128 (65.6%)      43 (63.2%)                 (−11.44%, p = 0.005), systolic BP (−1.49.0%, p = 0.046),
Comorbidities
                                                                          and diastolic BP (−3.410%, p < 0.001) but significant rela-
                                                                          tive increase in body weight (3.72%, p < 0.001). In the
    Numberb                   2.3 ± 0.8        3.0 ± 1.0
Tourkmani et al. BMC Family Practice (2018) 19:1                                                                                                       Page 6 of 10

Table 2 Paired post-pre changes (as a percent of the baseline) in HbA1c, blood glucose and lipids, blood pressure and body weight
among patients in the intervention and control groups
                      Mean ± SD of difference of relative                        Lower confidence         Upper confidence          Paired       df        P-value*
                      changes related to start of the study                                                                         t-test
Intervention
  HbA1c               −27.08 ± 12.90                                             −25.26                   −28.90                    −29.31       194
Tourkmani et al. BMC Family Practice (2018) 19:1                                                                                                 Page 7 of 10

  Fig. 3 a Comparison of different categories of HbA1c at enrollment and final stage of follow up. b Change in HbA1c category for both the
  intervention and control cohorts

Table 3 Absolute difference at the end of the study between intervention and control group, showed statistically significant difference
in HbA1c, FBG, Cholesterol, LDL and Body weight parameters with P value (
Tourkmani et al. BMC Family Practice (2018) 19:1                                                                                                          Page 8 of 10

Table 4 Correlation between the pre-post changes in HbA1c levels and certain patients’ personal and disease and service characteristics
                                                                               Spearman rank correlation
                               Total                                           Intervention                                  Control
                               HbA1c                HbA1c                      HbA1c             HbA1c                       HbA1c              HbA1c
                               (pre-post diff)      (pre-post diff % of pre)   (pre-post diff)   (pre-post diff % of pre)    (pre-post diff)    (pre-post diff % of pre)
HbA1c                          .992§                                           .984 §                                        .997§
(pre-post diff % of pre)
Age                            −0.03                −0.02                      −0.03             −0.01                       0.07               0.07
Duration of DM                 −0.11                −0.10                      −0.11             −0.10                       −0.54              −0.54
Insulin total                  .177§                .172§                      0.00              −0.01                       −0.01              −0.02
dose/kg Number of:
Comorbidities                  −.229§               −.232§                     0.03              0.03                        −0.02              −0.01
Insulin types                  .423 §
                                                    .427§
                                                                               −0.04             −0.05                       0.21               0.21
Oral drugs                     0.08                 0.07                       0.02              0.00                        −0.05              −0.03
All medications                .409§                .408§                      −0.02             −0.04                       0.17               0.18
Number of visits to:
Doctor                         −.184§               −.180§                     −0.05             −0.05                       0.11               0.11
Case manager                   .597 §
                                                    .612§
                                                                               .314§
                                                                                                 .331§
                                                                                                                             −0.06              −0.07
Dietitian                      −.214§               −.215§                     −0.08             −0.08                       0.02               0.02
DM educator                    .172§                .183§                      0.06              0.08                        0.19               0.20
Health educator                .479§                .491§                      0.10              0.10
Total visits                   .552§                .569§                      .303§             .321§                       0.11               0.11
DM diabetes mellitus
(§) Statistically significant at p < 0.01

specialized diabetes centers were shown to have poor                                    manager, may have improved insulin intensification that
diabetes control, with the ADA standards of diabetic                                    is not usually tackled by primary care physician [30, 31].
care not met [24–26]. Several challenges to proper dia-                                    The integrated care program in the current study was
betes management in primary care setting have been de-                                  associated with a considerably better lipid profile and a
scribed. These include insufficient patient education,                                  slight reduction in BP. Similar findings have been reported
inadequate patient adherence to medication, infrequent                                  before with a considerable increase in the number of those
clinic visits, lack of social support, lack of home blood                               with controlled total and LDL cholesterol and those with
glucose monitoring, inadequate physician attitude and                                   controlled BP after a multidisciplinary care [15, 19, 32–
approach, and system barriers [27–29]. The integrated                                   34]. However, the percentage changes in BP and, to a
care program described in this study was designed to                                    lesser extent, blood lipids in the current study were less
deal with all the above challenges.                                                     remarkable compared with glycemic control, probably in-
  The more frequent clinic visits were the only strategy                                dicating the need for more involvement by dietitians, es-
to predict improved HbA1c levels independently in the                                   pecially given that visits to dietitians were less frequent
current study. It appeared that several other components                                compared with other team members and were not differ-
of the integrated care program that were correlated in                                  ent between the intervention and control groups. It should
univariate analysis to improved HbA1c levels, such as                                   also be mentioned that the modest increase in body
appropriate insulin types and doses, are only working                                   weight that was observed in the intervention group in this
through multiple clinic visits. Additionally, the contribu-                             study and other studies may be related to increased insulin
tion of clinical pharmacist, who worked as the case                                     use among these patients [20].
Table 5 Best fitting multiple linear regression model for the improvement in the level of HbA1c after the intervention
                                            Unstandardized Coefficients            Standardized          t-test    p-value           95% Confidence Interval for B
                                                                                   Coefficients
                                            B                Std. Error                                                              Lower               Upper
Constant                                    4.82             0.53                                        9.09
Tourkmani et al. BMC Family Practice (2018) 19:1                                                                                                       Page 9 of 10

Limitations and strengths                                                          Availability of data and materials
The current study has the advantages of examining the                              The datasets used and/or analyzed during the current study available from
                                                                                   the corresponding author on reasonable request.
effects of a multidisciplinary, multifaceted integrated
care program on multiple outcomes and detecting the                                Authors’ contributions
predictors of improved glycemic control, using an ap-                              TA and AT are the guarantors of the data. Author Contributions: TA, AT, and
                                                                                   OA researched the data and wrote the manuscript; AM, AAlqahtani, and
propriate sample size and controlled design. Findings                              HAlqahtani researched the data and reviewed the manuscript; HAlkashan,
showed the impact of diabetes care conducted at the pri-                           AB, TE, AAlawad, AAlobaikan, AbR and AFA reviewed the manuscript and
mary care level was an appropriate model of care.                                  contributed to the discussion; AM and OA researched the data, reviewed
                                                                                   and edited the manuscript, and conducted the statistical analyses. All
Nevertheless, we acknowledge some limitations, such                                authors read and approved the final manuscript.
differences between the two groups at enrollment. How-
ever, these differences were not in one direction, were                            Ethics approval and consent to participate
                                                                                   The Prince Sultan Military Medical City ethical committee ethically approved
less clinically meaningful, and probably had no effect on                          this study. The ethical approval number SA555 and the clinical trial is
the study findings. For example, the patients in the con-                          registered under the number ISRCTN83437562. This study was conducted in
trol group, who had slightly more comorbidities, had                               accordance to all Saudi regulations. The participants signed an informed
                                                                                   consent for participation and publication.
slightly better glycemic control. Moreover, the differ-
ences in hypertension and dyslipidemia were not associ-                            Consent for publication
ated with differences in BP or blood lipids. The lack of                           Not applicable.

blindness for both patients and care providers may con-                            Competing interests
tribute to bias in the results. We tried to minimize such                          The authors declare that they have no competing interests.
effects by blinding the results to the outcomes assessors
(i.e., labs workers and nurses). Additionally, further re-                         Publisher’s Note
search encouraged to conduct to evaluate health eco-                               Springer Nature remains neutral with regard to jurisdictional claims in
                                                                                   published maps and institutional affiliations.
nomic during implementation of integrated care
program through multidisciplinary team approach.                                   Received: 9 March 2017 Accepted: 11 December 2017

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